Thursday, November 6, 2014

The FDA approves a Vaccine for a Rare Meningitis

Last fall an outbreak of a rare form of meningitis called serotype B occurred on the campus of Princeton University. Months later a similar outbreak occurred at the University of California Santa Barbara (UCSB). Although a vaccine against serotype B meningitis was available in Canada and Europe, it had not yet been approved in the U.S. Nevertheless, because of the dangerous nature of meningitis and the ease with which the disease might spread on college campuses (it's spread by close contact such as kissing or sharing eating utensils) the FDA granted emergency approval of the vaccine, just for students of Princeton and UCSB. The vaccine worked, the outbreaks subsided, and a greater crisis was averted.

Recognizing that the normal approval process for a vaccine or drug can take years, the FDA has developed a fast-track approval process for vaccines and drugs that meet certain criteria. Two competing vaccines against meningitis serotype B were fast-tracked under this program, and last week the FDA approved the first one, Pfizer's Trumenba.

And that's interesting, because the vaccine approved on an emergency basis for the students of Princeton and UCSB was the other vaccine, called Bexero, made by Novartis. We hope it's just that Pfizer just did a better (and faster) job of satisfying the FDA of its product's safety and effectiveness.

Now that a vaccine for meningitis serotype B is available, should it become part of the standard vaccination schedule for all children? That hasn't been decided yet, but the decision rests with the Centers for Disease Control and Prevention (CDC), not the FDA.

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